FDA Adverse Event
Malfunction
Summary report: N
TIGER SPINE SYSTEM
MDR report key: 3085188
·
Received April 3, 2013
Report
- Report Number
- 1935627-2013-00007
- Event Type
- Malfunction
- Date Received
- April 3, 2013
- Date of Event
- February 7, 2013
- Report Date
- March 22, 2013
- Manufacturer
- CORELINK, LLC
- Product Code
- MNH
- PMA / PMN Number
- K110321
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS COMPLAINT IS STILL UNDER INVESTIGATION. CORELINK WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.
Description of Event or Problem · 1
PHYSICIAN REPORTED DURING POST-OPERATIVE EVAL THAT A PEDICLE SCREW APPEARED TO BE BROKEN IN THE PT. THE PT'S INITIAL SURGERY WAS ON (B)(6) 2012.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 137756 | TIGER SPINE SYSTEM | PEDICLE SCREW SYSTEM | MNH | CORELINK, LLC | 55075-50 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |